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COOL ROM Knee orthosis-SHORT
EUDAMEDClass I (EU MDR)
Ref 12-0023-2Model 11-0021-40
by Orthobroker
Identity
- Trade Name
- COOL ROM Knee orthosis-SHORT EUDAMED
- Device Name
- BraceID- 0° Knee Immobiliser-40 EUDAMED
- Model / Reference
- 11-0021-40 EUDAMED12-0023-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404020402069 EUDAMED
- Basic UDI-DI
- 5404020402kneehipFJ EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
COOL ROM Knee orthosis-SHORT by Orthobroker — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5404020402kneehipFJ | Class I | Active |
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Manufacturer
- Manufacturer
- Orthobroker
- EUDAMED SRN
- BE-MF-000000331
Sources (1)
- EUDAMED 855a6aa8-fdca-47e1-b4b4-740ee2143557 61 fields · synced Jun 19, 2026